Study Raises Doubts Over Robotic Surgery

The use of robotic surgery for hysterectomies has grown dramatically in recent years, even though it costs one-third more than other minimally invasive surgery and has little added benefit, a major study said Tuesday.

The findings, in the Journal of the American Medical Association, are likely to raise new questions about whether the fast-growing surgical technology brings value to patients along with higher costs. Since 2000, 1,370 U.S. hospitals have purchased at least one of the $1.5 million-to-$2.2 million robots, known as the da Vinci Surgical Systems, made by Intuitive Surgical Inc. of Sunnyvale, Calif.

ENLARGE

A technician prepares the da Vinci Surgical System before a surgery at New Hanover Regional Medical Center in Wilmington, N.C., last year.
The Wilmington Star-News/Associated Press

The only such system for general surgery, da Vinci robots are used for a growing array of procedures, including prostate, gallbladder, cardiovascular and gynecological surgery.

In robotically assisted surgery, the surgeon sits at a console and operates four robotic arms that manipulate miniaturized tools inserted into the patient's body through small incisions. A tiny lighted camera displays the surgical field in 3-D on video screens.

Proponents say robotic surgery involves less scarring, less pain, less blood loss, fewer complications, shorter hospital stays and a faster recovery than traditional open surgery with a large incision that can take weeks to heal.

Critics say those advantages are due to the fact that it's a minimally invasive procedure, not that it's robotic: Conventional laparoscopic surgery, in which surgeons manipulate specialized tools and video camera by hand through small incisions, is also minimally invasive, at less cost.

For the new study, researchers at Columbia University examined the records of 264,758 women who had hysterectomies—removal of the uterus—for noncancerous conditions at 441 U.S. hospitals from 2007 to 2010. During that time, robotic surgery rose from 0.5% to nearly 10% of all the hysterectomies studied and 22% of those at hospitals where robotic surgery was offered. Laparoscopic procedures rose from 24% to 30%. Open surgeries dropped but were still the most common form of hysterectomy as of 2010. A fourth option, where the uterus is removed vaginally, remained about 20%.

ENLARGE

About 25% of the women who had laparoscopic hysterectomies stayed in the hospital longer than two days, compared with 20% of those who had robotic procedures. But the overall complication rate was the same—5%—for both groups.

The average total cost to the hospital for the robotic hysterectomy was $8,868, compared with $6,679 for a laparoscopic procedure and $6,651 for the open surgery.

"There are so many options for hysterectomies now that patients should discuss the pros and cons of all of them with their doctors," said the study's lead author, Jason Wright, an associate professor of women's health at Columbia University. The research was supported by a grant from the National Cancer Institute.

Myriam Curet, chief medical adviser for Intuitive Surgical, says robotic surgery should be compared with open, not laparoscopic, surgery: "We did not develop the robot to compete with laparoscopic surgery. We developed the robot to bring the benefits of minimally invasive surgery to more women."

Because robotic surgery is faster and easier to learn than laparoscopic techniques, more surgeons can offer it, the company says. The da Vinci also provides better access in complex cases such as when a patient is morbidly obese or her uterus is large—in part because the robotic tools have "wrists" on the end that bend many ways, Dr. Curet says.

"Robotic surgery does help me when I have to go really deep in the pelvis or use a lot of sutures," says gynecological surgeon Marie Paraiso at the Cleveland Clinic in Ohio, who uses both procedures. "But we haven't really defined which patients it helps most and it's never been shown to be cost-effective."

In a separate study published this week, Dr. Paraiso and colleagues randomly assigned 53 hysterectomy patients to either laparoscopic or robotic surgery. They found no significant differences in blood loss, pain or recovery between the groups, but the robotic surgery did take an average of 77 minutes longer than the laparoscopic version, which brings added costs.

The cost issue is complicated, however, because Medicare and private insurers generally reimburse hospitals the same amount for laparoscopic, robotic and open surgeries. Hospitals absorb the extra cost or pass it on to other patients, experts say. At the same time, many hospitals see robotic surgery as a marketing tool.

An editorial accompanying the JAMA study urged hospitals and surgeons to use caution in promoting robotic surgery in the absence of more evidence or decreases in price.

But hospitals may be reluctant to say no to new technologies. Michael Zinner, chairman of surgery at Brigham & Women's Hospital and co-author of the editorial, says robots may be a waste of money at small hospitals, but the two at Brigham are in such constant use that they are acquiring a third "and as a teaching hospital, we're pushing the technology as far as we can."

Rapidly Growing Technology Liked By Both Patients and Hospitals

Robotic surgery has grown rapidly since it was cleared by the Food and Drug Administration in 2000.

It gained popularity first among prostate surgeons, who like its precision in working with delicate male organs. By 2009, 85% of the 85,000 U.S. men who had prostate-cancer surgery had their prostates removed by the da Vinci system, according to its maker, Intuitive Surgical Inc. of Sunnyvale, Calif.

With uses expanding to lung, colon, pancreas, heart and gynecological surgery, more hospitals have invested in the robots. As of last year, 1,370 U.S. hospitals had purchased at least one da Vinci system, which costs roughly $2.2 million, plus add-ons and disposable tools. The robots have performed more than 1.5 million operations world-wide, the company says.

For now, the da Vinci is the only general-surgical robot on the market. MAKO Surgical Corp. of Fort Lauderdale, Fla., makes a robot for minimally invasive orthopedic procedures, and Mazor Robotics Ltd. of Caesarea, Israel, makes one for spinal repair.

Patients like robotic surgery because it speeds up recovery. And hospitals like to show they are on the cutting edge. "I've seen hospitals bring their robots to halftime shows at sporting events," said Martin A. Makary, an associate professor of surgery and health policy at Johns Hopkins University.

Still, Dr. Makary said there have been no randomized, controlled trials showing that patients fare better with robotic surgery than other minimally invasive surgery.

"We have tough choices to make about health-care expenditures," he said.

—Melinda Beck

Corrections & Amplifications The list price of the da Vinci Surgical System, made by Intuitive Surgical starts at $1 million, but can reach $2.3 million when add-ons are included. An earlier version of this article incorrectly said a system costs roughly $2.2 million plus add-ons and disposable tools.

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